MIRAKEL- benzocine 10%, resorcinol 1.5% cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Active ingredients Purpose Benzocaine 10% .........................................................External Analgesic Resorcinol 1.50%........................................................External Analgesic,

Available from:

Sanvio, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Uses temporary relief of pain, itching and discomfort associated with: ■ rashes ■ minor cuts ■ minor burns ■ minor skin irritations ■ insect bites Active ingredients Purpose Benzocaine 10% .........................................................External Analgesic Resorcinol 1.50%........................................................External Analgesic

Authorization status:

OTC monograph not final

Summary of Product characteristics

MIRAKEL- BENZOCINE 10%, RESORCINOL 1.5% CREAM
SANVIO, INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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SANVIO MIRAKEL CREAM
ACTIVE INGREDIENTS
Active ingredients Purpose
Benzocaine 10%
.........................................................External
Analgesic
Resorcinol
1.50%........................................................External
Analgesic
US ES
Uses temporary relief of pain, itching and discomfort associated with:
■ rashes
■ minor cuts
■ minor burns
■ minor skin irritations
■ insect bites
WARNINGS
Warnings
For external use only
When using this product ■ avoid contact with eyes ■ do not apply
over large areas of the body
Stop use and ask a doctor if ■ condition worsens or symptoms persist
for more than 7 days, or clear up and occur again within a few days
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center immediately.
KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center immediately.
DIRECTIONS
Directions
■ adults and children 12 years and older: apply small amount to
affected area not more than 3-4 times a day.
■ children under 12 years of age: consult a doctor
OTHER INFORMATION
Other Information ■ store at 20-25°C (68-77°F)
■ skin is more sensitive to sunlight when using this product.
■ keep tightly closed after use.
INACTIVE INGREDIENTS
Inactive ingredients aloe barbadensis (aloe vera) leaf extract,
butylated hydroxytoluene, carbomer, cetyl
alcohol, cholecalciferol, edetate disodium,
glyceryl monostearate, isopropyl palmitate,
maltodextrin, mentha piperita (peppermint) oil,
methylparaben, mineral oil, PEG-40 hydrogenated
castor oil, PEG-100 stearate,petrolatum,
propylene glycol, propyl-paraben, purified
water, retinyl palmitate, sodium lauryl sulfate,
thymus vulgaris (thyme) flower le